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Basic resuscitation practices, particularly bag-mask ventilation, reduce newborn deaths from respiratory depression. There is strong scientific premise for improving bag-mask ventilation with feedback strategies, but there are significant barriers to bedside feedback in low-resource settings. To address these barriers, we developed LIVEBORN, a mobile health application to support feedback for newborn resuscitations. LIVEBORN uses data on provider actions and the newborn’s condition entered in real-time by an observer to provide real-time guidance during resuscitation and support debriefing after resuscitation. In a pilot study, we designed and then evaluated strategies to incorporate LIVEBORN Feedback into clinical practice at two health facilities in the Democratic Republic of the Congo, with one facility allocated to real-time guidance and one to debriefing. Providers at each facility used a participatory research methodology called Trials of Improved Practices to design and refine their strategy prior to pilot testing. The primary outcome of the pilot study was the feasibility of observing resuscitation care with LIVEBORN, defined as the percentage of births observed using LIVEBORN with a threshold of at least 50% of births observed to achieve feasibility. We also evaluated usability with the System Usability Scale and explored midwives’ perceptions of LIVEBORN Feedback in focus group discussions. During the pilot test, we found both strategies to be feasible with 74% of births observed with LIVEBORN at the real-time guidance facility and 67% at the debriefing facility. The strategy was also sufficiently usable with a System Usability Scale median score of 68 (Q1 65, Q3 78). Midwives perceived LIVEBORN Feedback to be helpful and believed it could save lives, but sometimes disagreed with LIVEBORN Feedback’s guidance to ventilate. In conclusion, we identified context-specific, feasible strategies for incorporating LIVEBORN Feedback into clinical care. We are now evaluating the effectiveness of LIVEBORN Feedback in a randomized control trial.

Background Newborn deaths comprise nearly half of under-5 deaths in Ghana, despite the fact that skilled birth attendants (SBAs) are present at 68% of births, which implies that evidence-based care during labor, birth and the immediate postnatal period may be deficient. We assessed the effect of a low-dose, high-frequency (LDHF) training approach on long-term evidence-based skill retention among SBAs and impact on adverse birth outcomes. Methods From 2014 to 2017, we conducted a cluster-randomized trial in 40 hospitals in Ghana. Eligible hospitals were stratified by region and randomly assigned to one of four implementation waves. We assessed the relative risks (RRs) of institutional intrapartum stillbirths and 24-h newborn mortality in months 1–6 and 7–12 of implementation as compared to the historical control period, and in post-intervention facilities compared to pre-intervention facilities during the same period. All SBAs providing labor and delivery care were invited to enroll; their knowledge and skills were assessed pre- and post-training, and 1 year later. Results Adjusting for region and health facility type, the RR of 24-h newborn mortality in the 40 enrolled hospitals was 0·41 (95% CI 0·32–0·51; p  < 0.001) in months 1–6 and 0·30 (95% CI 0·21–0·43; p  < 0·001) in months 7–12 compared to baseline. The adjusted RR of intrapartum stillbirth was 0·64 (95% CI 0·53–0·77; p  < 0·001) in months 1–6 and 0·48 (95% CI 0·36–0·63; p  < 0·001) in months 7–12 compared to baseline. Four hundred three SBAs consented and enrolled. After 1 year, 200 SBAs assessed had 28% (95% CI 25–32; p  < 0·001) and 31% (95% CI 27–36; p  < 0·001) higher scores than baseline on low-dose 1 and 2 content skills, respectively. Conclusions This training approach results in a sustained decrease in facility-based newborn mortality and intrapartum stillbirths, and retained knowledge and skills among SBAs after a year. We recommend use of this approach for future maternal and newborn health in-service training and programs. Trial registration Retrospectively registered on 25 September 2017 at Clinical Trials, identifier NCT03290924 .

Background The ePartogram is a tablet-based application developed to improve care for women in labor by addressing documented challenges in partograph use. The application is designed to provide real-time decision support, improve data entry, and increase access to information for appropriate labor management. This study’s primary objective was to evaluate the feasibility and acceptability of ePartogram use in resource-constrained clinical settings. Methods The ePartogram was introduced at three facilities in Zanzibar, Tanzania. Following 3 days of training, skilled birth attendants (SBAs) were observed for 2 weeks using the ePartogram to monitor laboring women. During each observed shift, data collectors used a structured observation form to document SBA comfort, confidence, and ability to use the ePartogram. Results were analyzed by shift. Short interviews, conducted with SBAs ( n  = 82) after each of their first five ePartogram-monitored labors, detected differences over time. After the observation period, in-depth interviews were conducted ( n  = 15). A thematic analysis of interview transcripts was completed. Results Observations of 23 SBAs using the ePartogram to monitor 103 women over 84 shifts showed that the majority of SBAs (87–91%) completed each of four fundamental ePartogram tasks—registering a client, entering first and subsequent measurements, and navigating between screens—with ease or increasing ease on their first shift; this increased to 100% by the fifth shift. Nearly all SBAs (93%) demonstrated confidence and all SBAs demonstrated comfort in using the ePartogram by the fifth shift. SBAs expressed positive impressions of the ePartogram and found it efficient and easy to use, beginning with first client use. SBAs noted the helpfulness of auditory reminders (indicating that measurements were due) and visual alerts (signaling abnormal measurements). SBAs expressed confidence in their ability to interpret and act on these reminders and alerts. Conclusions It is feasible and acceptable for SBAs to use the ePartogram to support labor management and care. With structured training and support during initial use, SBAs quickly became competent and confident in ePartogram use. Qualitative findings revealed that SBAs felt the ePartogram improved timeliness of care and supported decision-making. These findings point to the ePartogram’s potential to improve quality of care in resource-constrained labor and delivery settings.

Background: The majority of newborn deaths occur during the first week of life, and 25‒45% occur within the first 24 hours. A low-dose, high-frequency (LDHF) training approach was introduced in 40 hospitals in Ghana to improve newborn survival. The aim of this qualitative study was to explore healthcare workers’ experiences with the LDHF approach to in-service training. Methods: A total of 20 in-depth interviews and nine focus group discussions were conducted in 2016 in three regions of Ghana with healthcare workers who participated in implementation of the LDHF training approach. In-depth interviews were conducted with 20 master mentors and peer practice coordinators; 51 practicing doctors, midwives and nurses participated in focus group discussions. Data were analyzed using a thematic analysis approach. Results: Healthcare workers reflected on the differences between the LDHF approach and past learning experiences, highlighting how the skills-based team training approach, coupled with high-frequency practice and mobile mentoring, built their competency and confidence. As participants shared their experiences, they highlighted relationships established between Master Mentors and healthcare workers, and motivation stemming from pride in contributing to reductions in maternal and newborn deaths as critical factors in improving quality of care at participating health facilities. Conclusion: This nested qualitative study documents experiences of healthcare workers and mentors involved in implementation of a multi-faceted intervention that effectively improved maternal and newborn care at health facilities in Ghana. The way the intervention was implemented created an environment conducive to learning within the hospital setting, thus providing an opportunity for professional growth and quality improvement for all staff working in the maternity ward.

Background At least 39 sub-Saharan African countries have policies on preventing malaria in pregnancy (MIP), including use of long-lasting insecticidal nets (LLINs), intermittent preventive treatment with sulphadoxine-pyrimethamine (IPTp-SP) and case management. However, coverage of LLINs and IPTp-SP remains below international targets in most countries. One factor contributing to low coverage may be that MIP policies typically are developed by national malaria control programmes (NMCPs), but are implemented through national reproductive health (RH) programmes. Methods National-level MIP policies, guidelines, and training documents from NMCPs and RH programmes in Kenya, Mali, Mozambique, mainland Tanzania and Uganda were reviewed to assess whether they reflected WHO guidelines for prevention and treatment of MIP, and how consistent MIP content was across documents from the same country. Documents were compared for adherence to WHO guidance concerning IPTp-SP timing and dose, directly observed therapy, promotion and distribution of LLINs, linkages to HIV programmes and MIP case management. Results The five countries reviewed had national documents promoting IPTp-SP, LLINs and MIP case management. WHO guidance from 2004 frequently was not reflected: four countries recommended the first dose of IPTp-SP at 20 weeks or later (instead of 16 weeks), and three countries restricted the first and second IPTp-SP doses to specific gestational weeks. Documents from four countries provided conflicting guidance on MIP prevention for HIV-positive women, and none provided complete guidance on management of uncomplicated and severe malaria during pregnancy. In all countries, inconsistencies between NMCPs and RH programmes on the timing or dose of IPTp-SP were documented, as was the mechanism for providing LLINs. Inconsistencies also were found in training documents from NMCPs and RH programmes in a given country. Outdated, inconsistent guidelines have the potential to cause confusion and lead to incorrect practices among health workers who implement MIP programmes, contributing to low coverage of IPTp-SP and LLINs. Conclusions MIP policies, guidelines and training materials are outdated and/or inconsistent in the countries assessed. Updating and ensuring consistency among national MIP documents is needed, along with re-orientation and supervision of health workers to accelerate implementation of the 2012 WHO Global Malaria Programme policy recommendations for IPTp-SP.

Basic resuscitation practices, particularly bag-mask ventilation, reduce newborn deaths from respiratory depression. There is strong scientific premise for improving bag-mask ventilation with feedback strategies, but there are significant barriers to bedside feedback in low-resource settings. To address these barriers, we developed LIVEBORN, a mobile health application to support feedback for newborn resuscitations. LIVEBORN uses data on provider actions and the newborn's condition entered in real-time by an observer to provide real-time guidance during resuscitation and support debriefing after resuscitation. In a pilot study, we designed and then evaluated strategies to incorporate LIVEBORN Feedback into clinical practice at two health facilities in the Democratic Republic of the Congo, with one facility allocated to real-time guidance and one to debriefing. Providers at each facility used a participatory research methodology called Trials of Improved Practices to design and refine their strategy prior to pilot testing. The primary outcome of the pilot study was the feasibility of observing resuscitation care with LIVEBORN, defined as the percentage of births observed using LIVEBORN with a threshold of at least 50% of births observed to achieve feasibility. We also evaluated usability with the System Usability Scale and explored midwives' perceptions of LIVEBORN Feedback in focus group discussions. During the pilot test, we found both strategies to be feasible with 74% of births observed with LIVEBORN at the real-time guidance facility and 67% at the debriefing facility. The strategy was also sufficiently usable with a System Usability Scale median score of 68 (Q1 65, Q3 78). Midwives perceived LIVEBORN Feedback to be helpful and believed it could save lives, but sometimes disagreed with LIVEBORN Feedback's guidance to ventilate. In conclusion, we identified context-specific, feasible strategies for incorporating LIVEBORN Feedback into clinical care. We are now evaluating the effectiveness of LIVEBORN Feedback in a randomized control trial.

Background: The majority of newborn deaths occur during the first week of life, and 25‒45% occur within the first 24 hours. A low-dose, high-frequency (LDHF) training approach was introduced in 40 hospitals in Ghana to improve newborn survival. The aim of this qualitative study was to explore healthcare workers’ experiences with the LDHF approach to in-service training. Methods: A total of 20 in-depth interviews and nine focus group discussions were conducted in 2016 in three regions of Ghana with healthcare workers who participated in implementation of the LDHF training approach. In-depth interviews were conducted with 20 master mentors and peer practice coordinators; 51 practicing doctors, midwives and nurses participated in focus group discussions. Data were analyzed using a thematic analysis approach. Results: Healthcare workers reflected on the differences between the LDHF approach and past learning experiences, highlighting how the skills-based team training approach, coupled with high-frequency practice and mobile mentoring, built their competency and confidence. As participants shared their experiences, they highlighted relationships established between Master Mentors and healthcare workers, and motivation stemming from pride in contributing to reductions in maternal and newborn deaths as critical factors in improving quality of care at participating health facilities. Conclusion: This nested qualitative study documents experiences of healthcare workers and mentors involved in implementation of a multi-faceted intervention that effectively improved maternal and newborn care at health facilities in Ghana. The way the intervention was implemented created an environment conducive to learning within the hospital setting, thus providing an opportunity for professional growth and quality improvement for all staff working in the maternity ward.

Sacituzumab govitecan demonstrated significant progression-free survival benefit over chemotherapy in the phase 3 TROPiCS-02 trial in patients with pretreated, endocrine-resistant hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+ and HER2–) metastatic breast cancer with limited treatment options. Here, we report the protocol-specified final analysis of overall survival and endpoints by trophoblast cell-surface antigen 2 (Trop-2) expression and other variables. In this randomised, open-label, multicentre, phase 3 trial, which took place in 91 centres across North America (the USA and Canada) and Europe (Belgium, France, Germany, Italy, the Netherlands, Spain, and the UK), patients were randomly assigned (1:1) to receive sacituzumab govitecan or chemotherapy (eribulin, vinorelbine, capecitabine, or gemcitabine). Patients had confirmed HR+ and HER2– locally recurrent inoperable or metastatic breast cancer and had received at least one previous endocrine therapy, a taxane, and a CDK4/6 inhibitor in any setting and two to four previous chemotherapy regimens for metastatic disease. The primary endpoint was progression-free survival (previously reported and not included in this analysis), and secondary endpoints included overall survival, objective response rate (ORR), and patient-reported outcomes. Overall survival was assessed using stratified log-rank tests and Cox regression. Trop-2 expression was assessed in tumour tissue by immunohistochemistry. In the statistical testing hierarchy, ORR and patient-reported outcomes were tested sequentially if overall survival was significant. This study is registered with ClinicalTrials.gov, NCT03901339. At the data cutoff date of July 1, 2022, 543 of 776 screened patients were randomly assigned between May 30, 2019, and April 5, 2021, with 272 patients in the sacituzumab govitecan group and 271 patients in the chemotherapy group. With a 12·5-month (IQR 6·4–18·8) median follow-up, 390 deaths occurred among 543 patients. Overall survival was significantly improved with sacituzumab govitecan versus chemotherapy (median 14·4 months [95% CI 13·0–15·7] vs 11·2 months [10·1–12·7]; hazard ratio [HR] 0·79, 95% CI 0·65–0·96; p=0·020); survival benefit was consistent across Trop-2 expression-level subgroups. ORR was significantly improved with sacituzumab govitecan compared with chemotherapy (57 [21%] patients vs 38 [14%]; odds ratio 1·63 [95% CI 1·03–2·56]; p=0·035), as was time to deterioration of global health status and quality of life (median 4·3 months vs 3·0 months; HR 0·75 [0·61–0·92]; p=0·0059) and fatigue (median 2·2 months vs 1·4 months; HR 0·73 [0·60–0·89]; p=0·0021). The safety profile of sacituzumab govitecan was consistent with previous studies (including the TROPiCS-02 primary analysis and the ASCENT trial). One fatal adverse event (septic shock caused by neutropenic colitis) was determined to be related to sacituzumab govitecan treatment. Sacituzumab govitecan demonstrated statistically significant and clinically meaningful benefit over chemotherapy, with a 3·2-month median overall survival improvement and a manageable safety profile. These data support sacituzumab govitecan as a new treatment option for patients with pretreated, endocrine-resistant HR+ and HER2– metastatic breast cancer. Gilead Sciences.

The death of a loved one was a challenge many people faced during the COVID-19 pandemic within the context of extraordinary circumstances and great uncertainty. Grief is an unavoidable part of life, and for most people, feelings of grief decrease naturally over time. However, for some people, grieving can become a particularly painful process with clinical symptoms that may require professional help to resolve. To provide psychological support to people who had lost a loved one during the COVID-19 pandemic, an unguided web-based psychological intervention was developed. The main objective of this study was to evaluate the efficacy of the web-based treatment, Grief COVID (Duelo COVID in Spanish; ITLAB), in reducing clinical symptoms of complicated grief, depression, posttraumatic stress, hopelessness, anxiety, and suicidal risk in adults. The secondary aim was to validate the usability of the self-applied intervention system. We used a randomized controlled trial with an intervention group (IG) and a waitlist control group (CG). The groups were assessed 3 times (before beginning the intervention, upon completing the intervention, and 3 months after the intervention). The intervention was delivered on the web in an asynchronous format through the Duelo COVID web page. Participants created an account that could be used on their computers, smartphones, or tablets. The evaluation process was automated as part of the intervention. A total of 114 participants were randomly assigned to the IG or CG and met criteria for inclusion in the study (n=45, 39.5% completed the intervention and n=69, 60.5% completed the waitlist period). Most participants (103/114, 90.4%) were women. The results indicated that the treatment significantly reduced baseline clinical symptoms in the IG for all variables (P<.001 to P=.006), with larger effect sizes for depression, hopelessness, grief, anxiety, and risk of suicide (all effect sizes ≥0.5). The follow-up evaluation showed that symptom reduction was maintained at 3 months after the intervention. The results from the CG showed that participants experienced significantly decreased levels of hopelessness after completing the time on the waitlist (P<.001), but their suicidal risk scores increased. Regarding the usability of the self-applied intervention system, the results indicated a high level of satisfaction with the Grief COVID. The self-applied web-based intervention Grief COVID was effective in reducing symptoms of anxiety, depression, hopelessness, risk of suicide risk, posttraumatic stress disorder, and complicated grief disorder. Grief COVID was evaluated by the participants, who reported that the system was easy to use. These results affirm the importance of developing additional web-based psychological tools to help reduce clinical symptoms in people experiencing grief because of the loss of a loved one during a pandemic. ClinicalTrials.gov NCT04638842; https://clinicaltrials.gov/ct2/show/NCT04638842.

SummaryBackgroundWe aimed to report on long-term outcomes of patients with small, node-negative, HER2-positive breast cancer treated with adjuvant paclitaxel and trastuzumab and to establish potential biomarkers to predict prognosis. MethodsIn this open-label, single-arm, phase 2 study, patients aged 18 years or older, with small (≤3 cm), node-negative, HER2-positive breast cancer, and an Eastern Cooperative Oncology Group performance status of 0–1, were recruited from 16 institutions in 13 cities in the USA. Eligible patients were given intravenous paclitaxel (80 mg/m 2) with intravenous trastuzumab (loading dose of 4 mg/kg, subsequent doses 2 mg/kg) weekly for 12 weeks, followed by trastuzumab (weekly at 2 mg/kg or once every 3 weeks at 6 mg/kg) for 40 weeks to complete a full year of trastuzumab. The primary endpoint was 3-year invasive disease-free survival. Here, we report 10-year survival outcomes, assessed in all participants who received protocol-defined treatment, with exploratory analyses using the HER2DX genomic tool. This study is registered on ClinicalTrials.gov, NCT00542451, and is closed to accrual. FindingsBetween Oct 29, 2007, and Sept 3, 2010, 410 patients were enrolled and 406 were given adjuvant paclitaxel and trastuzumab and included in the analysis. Mean age at enrolment was 55 years (SD 10·5), 405 (99·8%) of 406 patients were female and one (0·2%) was male, 350 (86·2%) were White, 28 (6·9%) were Black or African American, and 272 (67·0%) had hormone receptor-positive disease. After a median follow-up of 10·8 years (IQR 7·1–11·4), among 406 patients included in the analysis population, we observed 31 invasive disease-free survival events, of which six (19·4%) were locoregional ipsilateral recurrences, nine (29·0%) were new contralateral breast cancers, six (19·4%) were distant recurrences, and ten (32·3%) were all-cause deaths. 10-year invasive disease-free survival was 91·3% (95% CI 88·3–94·4), 10-year recurrence-free interval was 96·3% (95% CI 94·3–98·3), 10-year overall survival was 94·3% (95% CI 91·8–96·8), and 10-year breast cancer-specific survival was 98·8% (95% CI 97·6–100). HER2DX risk score as a continuous variable was significantly associated with invasive disease-free survival (hazard ratio [HR] per 10-unit increment 1·24 [95% CI 1·00–1·52]; p=0·047) and recurrence-free interval (1·45 [1·09–1·93]; p=0·011). InterpretationAdjuvant paclitaxel and trastuzumab is a reasonable treatment standard for patients with small, node-negative, HER2-positive breast cancer. The HER2DX genomic tool might help to refine the prognosis for this population. FundingGenentech.